Warm Pads Applied to the Breast During Episiotomy Repair

Breastfeeding Clinical Trial

Official title:

The Effect of Warm Pads Applied to the Breast During Episiotomy Repair on the Amount of Milk, Breastfeeding Motivation and the Perception of Insufficient Milk

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06119646
• Other study ID #: 223278001012
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: November 2023
• Source: Selcuk University
• Contact: Bilnur SILAY
• Phone: +90 332 241 50 00
• Email: seltip[@]selcuk.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

H1-1 Hypothesis: Warm pads applied to the breast during episiotomy repair in the intervention group will have an effect on increasing milk production compared with the control group.

H1-2 Hypothesis: Warm pads applied to the breast of the intervention group during episiotomy repair will have an effect on increasing breastfeeding motivation compared to the control group.

H1-3 Hypothesis: Warm pads applied to the breast of the intervention group during episiotomy repair will have an effect on reducing the mother's perception of insufficient milk compared to the control group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: August 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• First pregnancy,

• Those who are 18 years or older,

• Can speak Turkish and express themselves in Turkish,

• Do not have any disability (such as sight, hearing),

• Gave birth after >37 weeks of pregnancy,

• Who have had a normal birth and have had an episiotomy,

• There is no open wound on the breast,

• A singleton pregnancy,

• Women who are open to communication and mentally and emotionally healthy.

Exclusion Criteria:

• Those who do not agree to work

• Those who want to leave for any reason during the application process

• Having postpartum haemorrhage,

• Women who develop any postpartum complications,

• Women whose babies are admitted to the neonatal intensive care unit.

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Other:
• Warm Pads Applied to the Breast
Applying a warm pad to a breast during episiotomy repair

Locations

Country	Name	City	State
Turkey	Selcuk University Faculty of Medicine Hospital	Konya	Selçuklu

Sponsors (2)

Lead Sponsor	Collaborator
Selcuk University	Lansinoh Laboratories

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

An official position statement of the Association of Women's Health, Obstetric and Neonatal Nurses. Breastfeeding and the Use of Human Milk. Nurs Womens Health. 2021 Oct;25(5):e4-e8. doi: 10.1016/j.nwh.2021.06.005. Epub 2021 Jul 22. No abstract available. — View Citation

Gökçeoglu, E. ve Küçükoglu, S. (2018). Validity and Reliability Study of Perception of Insufficient Milk Supply Questionnaire for Turkish Society. International Journal of Innovative Research and Reviews, 2(2), 15-20.

Lin, L. ve Zhang, T. (2011). Playing exergames in the classroom: Pre-service teachers' motivation, passion, effort, and perspectives. JTATE, 19(3), 243-260.

McCarter-Spaulding DE, Kearney MH. Parenting self-efficacy and perception of insufficient breast milk. J Obstet Gynecol Neonatal Nurs. 2001 Sep-Oct;30(5):515-22. doi: 10.1111/j.1552-6909.2001.tb01571.x. — View Citation

Ryan RM, Deci EL. Intrinsic and Extrinsic Motivations: Classic Definitions and New Directions. Contemp Educ Psychol. 2000 Jan;25(1):54-67. doi: 10.1006/ceps.1999.1020. — View Citation

Saus-Ortega C. Promoting correct positioning and attachment in breastfeeding infants born by section cesarean in the La Fe Hospital in Spain: a best-practice implementation project. JBI Evid Implement. 2020 Sep;18(3):297-307. doi: 10.1097/XEB.000000000000 — View Citation

Stockdale J, Sinclair M, Kernohan G, McCrum-Gardner E, Keller J. Sensitivity of the breastfeeding motivational measurement scale: a known group analysis of first time mothers. PLoS One. 2013 Dec 31;8(12):e82976. doi: 10.1371/journal.pone.0082976. eCollect — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Introductory Information Form	The Introductory Information Form is a 15-item survey form prepared by researchers based on the literature. The Introductory Information Form includes 10 questions on socio-demographic characteristics of pregnant women and their partners and 5 questions on obstetric characteristics of pregnant women.	pre-intervention
Primary	Postpartum Milk Expression and Amount Information Form	Postpartum Milk Expression and Amount Information Form aims to be evaluated by researchers by asking 8 questions to the intervention group and 6 questions to the control group. The questions were prepared by the researcher. There are statements that need to be measured quantitatively and recorded by the researcher.	in the first hour in postpartum period
Secondary	Primiparous Breastfeeding Motivation Scale (PBMS)	The scale, whose Turkish validity and reliability was confirmed by Akçay and Demirgöz Bal in 2019, was published by Stockdale et al. in 2013. PBMS is a 37-item scale developed to evaluate the postnatal breastfeeding motivation in primipara. The scale has four sub-dimensions of "The value placed on breastfeeding", "Self-efficacy", "Perceived support from the midwife" and "Expectation of success". High scores from the scale indicate high breastfeeding motivation, low scores indicate low breastfeeding motivation.	in the second hour in postpartum period
Secondary	Perception of Insufficient Milk Supply Questionaire	The scale, developed by McCarter-Spaulding and Kearney in 2001, consists of 6 questions to determine the perception of insufficient breast milk. The Turkish validity and reliability of the scale was conducted by Gökçeoglu and Küçükoglu in 2014. The first question of the scale asks whether the mother feels that her milk is sufficient, and is answered with 'yes' or 'no'. Other questions on the scale aim to measure the perception of milk inadequacy. These questions are scored on a scale from 0 to 10 ('0' means the milk is perceived as completely inadequate, '10' means the milk is perceived as completely sufficient). The scale can produce scores from 0 to 50, and a higher total score indicates an increasing perception of milk adequacy.	in the second hour in postpartum period